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Diagnostic and Therapeutic Applications of Microarrays in Lung Transplantation (INTERLUNG)

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ClinicalTrials.gov Identifier: NCT02812290
Recruitment Status : Recruiting
First Posted : June 24, 2016
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
Philip Halloran, University of Alberta

Brief Summary:
Objective: To evaluate the potential impact of molecular phenotyping of transbronchial biopsies in lung transplant recipients with allograft dysfunction, and the potential for developing a safer endobronchial mucosal biopsy format.

Condition or disease Intervention/treatment
Lung Transplant Rejection Procedure: Lung transplant biopsy bites.

Detailed Description:
The current standard for biopsy-based diagnoses of dysfunction of lung transplants is the International Society of Heart and Lung Transplantation (ISHLT) classification applied to transbronchial biopsies, which represents an arbitrary international consensus. Recent data-driven approaches using molecular and conventional technologies indicate that this system produces frequently incorrect diagnoses with potential harm to patients due to inappropriate treatment. especially in relationship to the correct diagnosis of chronic lung allograft dysfunction is a pressing need. To address this unmet need and improve diagnostics in the area of organ transplantation, the Alberta Transplant Applied Genomics Centre (ATAGC, University of Alberta) has developed a new diagnostic system - the Molecular Microscope® Diagnostic System (MMDx) that interprets biopsies in terms of their molecular phenotype. The MMDx, developed first in kidney transplant biopsies with thoroughly established phenotypes, will now be adapted to lung transplant transbronchial biopsies (TBBs). Microarray analysis of lung allograft biopsy specimens will be compared to conventional allograft phenotyping, including clinical, physiologic, radiographic and histological assessment. The present study will use the MMDx™ system to assess and report TBBs, and validate and refine this system in 300 unselected prospectively collected lung TBBs. A subset of the study will examine the third bifurcation mucosal endobronchial biopsies (3BMBs) paired with TBBs from 50 patients to see if the safer 3BMBs can substitute for the TBB to be used by MMDx™. Due to a considerable interest and support from participating Centers, the study is further extended and collected 818 TBBs and 657 3BMBs from 657 patients. Thus this is the extension of the INTERLUNG study - INTERLUNGEX.

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-Centric Observational Study to Analyze the Diagnostic Molecular Features in the Clinical Setting of Lung Allograft Biopsies
Study Start Date : May 2016
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Lung transplant biopsy bites.
    In the second phase of the study, two biopsy bites from the same patient will be collected to assess tissue sampling variability.


Primary Outcome Measures :
  1. Report the molecular scores (probability) of lung transplant disease in a reference set of 600 transbronchial biopsies. [ Time Frame: two years ]
    Molecular classifier predicts antibody mediated and T cell mediated rejection, and chronic allograft dysfunction.

  2. Report the molecular diagnoses of the MMDx-TBB system [ Time Frame: two years ]
    Compare MMDx readings to standard-of-care TBB histology and clinical diagnosis of CLAD.


Secondary Outcome Measures :
  1. Report the molecular scores (probability) of lung transplant disease in a reference set of 600 mucosal endobronchial biopsies. [ Time Frame: two years ]
    Molecular classifier predicts antibody mediated and T cell mediated rejection, and chronic allograft dysfunction.

  2. Report the molecular diagnoses of the MMDx-3BMB system [ Time Frame: two years ]
    Compare MMDx-3BMB readings to MMDx-TBB readings and clinical diagnosis of CLAD

  3. Report the molecular changes over time in medically indicated follow-up biopsies [ Time Frame: two years ]
    Predict and monitor response to anti-rejection treatment.


Biospecimen Retention:   Samples Without DNA
Lung transplant biopsies taken as per local standard of care.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with functioning lung transplant biopsied to determine their graft dysfunction or to confirm good function as per standard of care.
Criteria

Inclusion Criteria:

  • All lung transplant recipients undergoing a biopsy as determined by their surgeon or physician.

Exclusion Criteria:

  • Patients who declined participation or unable to give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812290


Contacts
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Contact: Konrad S Famulski, PhD 1 780 492 1725 konrad@ualberta.ca
Contact: Robert Polakowski, PhD 1 780 492 5091 polakows@ualberta.ca

Locations
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United States, Maryland
University of Maryland School of Medicine Suspended
Baltimore, Maryland, United States, 21201
United States, Missouri
Division of Pulmonary and Critical Care, Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Daniel Kreisel, MD, PhD    314-362-6021    kreiseld@wudosis.wustl.edu   
Principal Investigator: Daniel Kreisel, MD, PhD         
Sub-Investigator: Elbert Trulock, MD, PhD         
Sub-Investigator: Ramsey Hachem, MD         
United States, Texas
University of Texas at San Antonio Recruiting
San Antonio, Texas, United States, 21201
Contact: Deborah Jo Levine, MD       levinedj@uthscsa.edu   
Principal Investigator: Deborah Jo Levine         
Australia
The Alfred Hospital, Monash University Recruiting
Melbourne, Australia
Contact: Glen Westall, MD, PhD    +61 3 9076 2405    g.westall@alfred.org.au   
Principal Investigator: Glen Westall, MD, PhD         
Principal Investigator: Greg Snell, Professor         
Austria
Department of Thoracic Surgery, Medical University of Vienna Recruiting
Vienna, Austria
Contact: Walter Klepetko, MD, PhD    +43-1-40400-5644      
Principal Investigator: Walter Klepetko, MD, PhD         
Principal Investigator: Peter Jaksch, MD, PhD         
Canada, Alberta
Alberta Transplant Applied Genomics Centre, University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2E1
Contact: Konrad S Famulski, PhD    1 780 492 1725    konrad@ualberta.ca   
Principal Investigator: Philip F Halloran, MD, PhD         
Department of Medicine, University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2G3
Contact: Kieran Halloran, MD    1 780 492 2691    kieran.halloran@ualberta.ca   
Principal Investigator: Kieran Halloran, MD         
Sub-Investigator: Justin Weinkauf, MD         
Sub-Investigator: Alim Hirji, MD         
Canada, Ontario
University Health Network, Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Shaf Keshavjee, MD, MSc    1 416-340-3863    shaf.keshavjee@uhn.ca   
Principal Investigator: Shaf Keshavjee, MD, MSc         
Principal Investigator: Stephen Juvet, MD, PhD         
Czechia
Charles University/Hospital Motol Recruiting
Prague, Czechia
Contact: Jan Havlin, Dr       havlin.jan@gmail.com   
Principal Investigator: Jan Havlin, Dr         
Poland
Thoracic Surgery Transplant Clinic Recruiting
Szczecin, Poland, 70891
Contact: Bartosz Kupisa, PhD    48601720972    abkubisa@hotmail.com   
Principal Investigator: Bartosz Kupisa, PhD         
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Philip F Halloran, MD, PhD Faculty of Medicine and Dentistry, University of Alberta
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Philip Halloran, Distinguished Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT02812290    
Other Study ID Numbers: ATAGC 03
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Philip Halloran, University of Alberta:
antibody mediated rejection
T cell mediated rejection